BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONS PV .018 INTRAVASCULAR ULTRASOUND IMAGI

    MDR report key: 4955905 · Received July 29, 2015

    Report

    Report Number
    2939520-2015-00044
    Event Type
    Injury
    Date Received
    July 29, 2015
    Date of Event
    June 29, 2015
    Report Date
    June 30, 2015
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    IYO
    PMA / PMN Number
    K944004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REFERENCE: (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO VOLCANO POLICY. THE CUSTOMER REPORTED NO VISUAL DAMAGE WAS OBSERVED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING PRIOR TO THE PROCEDURE. A PRE-DECONTAMINATION VISUAL INSPECTION WAS PERFORMED ON THE DEVICE. THE DISTAL TIP, SCANNER AND PROXIMAL END OF THE WELD LEGS WERE NOT RETURNED. THE OUTER LUMEN, INNER LUMEN AND POLYIMIDE TUBE ALL SHOWED EVIDENCE OF STRETCHING AT THE POINT OF SEPARATION. THERE WAS MORE EVIDENCE OF STRETCHING OF THE CATHETER OBSERVED PROXIMAL TO THE POINT OF SEPARATION. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THERE WERE NO NONCONFORMING MATERIAL REPORTS OR DEVIATIONS NOTED THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE MODE. TO DATE, NO OTHER COMPLAINTS WERE REPORTED FOR THIS SAME FAILURE MODE WITHIN THIS LOT. WE WILL CONTINUE TO MONITOR THESE TYPES OF COMPLAINTS VIA COMPLAINT REVIEW MEETINGS AND TREND DATA.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE CASE THE VISIONS PV .018 IVUS CATHETER WAS SEPARATED AND THE DISTAL TIP REMAINED IN THE FALSE CHANNEL OF THE LESION INSIDE THE BODY. AN EN SNARE WAS USED TO ATTEMPT RETRIEVAL, BUT THE TIP COULD NOT BE RETRIEVED. FINALLY THE TRUE LUMEN OF THE LESION WAS DILATED BY A SAPPHIRE II PA AND A SMARTSTENT WAS PLACED IN THE LESION TO SECURE THE TIP OF THE VESSEL WALL. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE (VOLCANO EAGLE EYE PLATINUM. VESSEL: ILIAC, APPROACH: IPSILATERALLY FROM FEMORAL ARTERY (FA), OCCLUSION: CHRONIC TOTAL OCCLUSION (CTO), CALCIFICATION: SEVERE. NO ADDITIONAL INTERVENTION WAS REQUIRED. PATIENT WAS DISCHARGED AS EXPECTED WITH NO REPORTED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494627 VISIONS PV .018 INTRAVASCULAR ULTRASOUND IMAGI SYSTEM, IMAGING, PULSED ECHO, ULTRASONI IYO VOLCANO CORPORATION 86700 003 20025946

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention